Pharmacy Inspection Basics

To prepare for an inspection:

  • Be familiar with your state board of pharmacy’s (or province College of Pharmacists’) current requirements (most can be accessed through their websites). Many have resources such as checklists to help you prepare for their visits.2,3
  • Be familiar with current requirements of regulatory agencies and organizations (e.g., Centers for Medicare and Medicaid Services [CMS, U.S.], Drug Enforcement Agency [DEA, U.S.], Food and Drug Administration [FDA, U.S.], Joint Commission [hospital only, U.S.], Office of Controlled Substances [OCS, Canada], Pharmacy Compounding Accreditation Board [PCAB, U.S.]). Most have resources such as checklists to help you prepare for their visits.
  • Be prepared at all times. In the U.S., inspections may be unannounced.1 If you do receive notice of an inspection, consider whether additional staff will be needed on the day(s) of the inspection.4
  • Avoid behaviors that can lead to violations such as staff not wearing identification badges, not keeping pharmacy shelves clean, storing food in refrigerators meant for meds, etc.
  • Consider conducting mock inspections periodically to help identify deficiencies. The different agencies and organizations may have guides for these available on their websites.
  • Ensure pharmacy and staff (including any students) credentials are up-to-date (e.g., certification, licensure, registration).1 Remove credentials for any staff that are no longer employed.
  • Keep policy and procedure manuals up-to-date with required documents (e.g., job descriptions, emergency procedures, compounding policies).4,5
  • Ensure pharmacy documentation is accurate, complete, and up-to-date (e.g., controlled substance inventory, performance reviews, refrigerator and freezer temperature logs, training logs).5,6
  • Ensure all staff can access pertinent documents such as policy and procedure manuals.
  • Ensure accuracy and completeness when processing prescriptions (e.g., days’ supply, drug, sig) and that patient information such as allergy history is entered into the computer.2,6
  • Follow your pharmacy’s policies for keeping expired meds off of pharmacy shelves.

During an inspection:

  • Ask inspectors for identification before allowing pharmacy access.5
  • Answer questions honestly and concisely.5 Don’t offer additional information that has not been requested.
  • Don’t guess if you don’t know the answer to a question. Instead, say where you would go to find the answer, and ask if inspectors would like you to retrieve it.
  • Retrieve requested documentation efficiently.
  • Consider taking notes during the inspection.5

After an inspection:

  • Review internal notes and help implement and deploy plans to make any necessary changes.
  • Verify the timeframe your pharmacy was given to make any corrections. Be aware that this timeframe may be relatively short, such as within 10 to 14 days.2,3
  • Work as a team to ensure required corrections are made before inspectors return or before submission of corrective actions taken is required.
  • Help gather information to support any disputes against findings. Ensure that you meet the deadline for submitting this information, such as within 30 days.4

Project Leader in preparation of this clinical resource (331013): Stacy A. Hester, R.Ph., BCPS, Associate Editor

References

  1. The Joint Commission. Joint Commission FAQ page. https://www.jointcommission.org/about/jointcommissionfaqs.aspx. (Accessed September 7, 2017).
  2. Washington State Department of Health. Pharmacy Commission. Tips for passing your community pharmacy inspection. http://www.doh.wa.gov/LicensesPermitsandCertificates/ProfessionsNewReneworUpdate/
    PharmacyCommission/Inspections/InspectionTips
    . (Accessed September 7, 2017).
  3. West Virginia Board of Pharmacy. Inspections. http://www.wvbop.com/index.php?option=com_content&view=article&id=51&Itemid=56. (Accessed September 7, 2017).
  4. Leuck S. Pharmacy compliance audits: what pharmacies can expect. July 7, 2016. http://www.pharmacytimes.com/contributor/steve-leuck-pharmd/2016/07/pharmacy-compliance-audits-what-pharmacists-can-expect. (Accessed September 7, 2017),
  5. Houck LK. The nuts and bolts of preparing for and managing DEA cyclic investigations: what every registrant should know. June 19, 2014. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/06/the-nuts-and-bolts-of-preparing-for-and-managing-dea-cyclic-inspections-what-every-registrant-should.html. (Accessed September 7, 2017).
  6. Health Canada. Community pharmacy inspection program annual report, fiscal year 2015-2016. http://www.hc-sc.gc.ca/dhp-mps/pubs/compli-conform/community-pharmacy-inspection-pharmacies-communautaires/index-eng.php. (Accessed September 7, 2017).

Cite this document as follows: Clinical Resource, Pharmacy Inspection Basics. Pharmacist’s Letter/Prescriber’s Letter. October 2017.

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